Deregulating stem cell quackery in Italy? A bad omen.

At least, if you listen to what docs and "practitioners" who run stem cell clinics in various parts of the world, usually where regulation is lax and money from First World clientele is much sought after, that's what you could easily come to believe. Unfortunately, it's not just Third World countries in which "stem cell clinics" have proliferated. For instance, they are not nearly uncommon enough in Europe. The example that is most troubling right now is Italy, and the reason is that there is currently a law being considered that would greatly weaken the regulation of stem cell therapies, so much so that on Friday I saw something that's fairly rare: a major scientific journal published a pointed editorial about this new law, specifically EMBO Journal published a commentary by an international group of scientists warning about the path that the government of Italy is considering entitled Regulation of stem cell therapies under attack in Europe: for whom the bell tolls.

Stem cell quackery is a very popular form of quackery these days because, well, stem cells are so magical-seeming. You can now find stem cell treatments offered for autism (one of which, offered at a clinic in Costa Rica, I've discussed before and involves injecting "stem cells" into the cerebrospinal fluid of autistic children for a cool $15,000). Kent Heckenlively, the man who took his daughter to the aforementioned Costa Rica clinic for this treatment is not alone in subjecting his autistic child to such unproven uses of stem cells. Just a couple of months ago, a broadcast journalist in the Philippines named Karen Davila took her autistic son to the Villa Medica Clinic in Germany, which offers variants of stem cell therapy. One is known as "fresh cell therapy" and involves harvesting cells from lamb fetuses and injecting them into the patient. The other is called fat stem cell repair therapy, which is claimed to involve harvesting fat from the patient's abdomen or thigh and then isolating "stem cells" from them to be injected back into the patient's body.

There's also a variation on this "stem cell" theme in China, discussed by Steve Novella a few years ago, in which Dr. Hongyun Huang runs a clinic in which he injects "stem cells" claimed to be derived from olfactory sheath cells taken from aborted fetuses into the cerebrospinal fluid of patients suffering from spinal cord injury or motor neuron disease like amyotropic lateral sclerosis (Lou Gehrig's disease), claiming what can only be referred to as miraculous cures, sadly credulously reported by the press. He's a little more expensive, in that he charges $20,000 (or at least he did back in 2008, when Steve wrote his post).

It's not just neurological diseases and conditions for which stem cell treatments are offered, though. Dubious "stem cell" treatments can be easily found for virtually any disease that is currently incurable, chronic, or only treatable with great effort and not-so-great success. The list of diseases and conditions include, in addition to developmental disorders such as autism, neurological injury, and degenerative neurological diseases such as multiple sclerosis, diseases as diverse as heart disease, autoimmune diseases, respiratory disease, HIV/AIDS, diabetes, hypertension, cancer, and, of course, anti-aging. Truly, there is seemingly no disease for which some clinic, somewhere in the world (usually in Central America and China, but sometimes in Germany and the former Soviet Union) won't be claiming miraculous cures with "stem cells."

One example, a clinic in the Ukraine called EmCell, advertises its wares with slickly produced infomercials, chock full of impressive-appearing graphics and animations:

It's hard not to note that 1994, the year that this clinic came into existence, was long before legitimate stem cell therapy, other than bone marrow transplantation, had progressed to anywhere near being a viable therapy. Notice the claims of patents, mostly in Russia and the Ukraine, but a few European patents and a couple of US patents as well. I looked at one of the US patents. All it is is a method to prepare a "cell suspension" from human embryo that, or so it is claimed, is suitable for treating HIV. You know what you don't see on the website? Solid evidence from randomized clinical trials. There are, however, many testimonials. It doesn't help that well-known antivaccinationist and autism quack (in my opinion) Jeff Bradstreet is apparently the U.S. contact for EmCell.

Of course, EmCell is far from alone; it's just one of the older and slicker "stem cell" clinics. There are many others, such as the Stem Cell Institute in Panama, the Bio-Cellular Research Organization in Ireland, the Regenerative Medicine Institute in Tijuana, among many others. Astute readers might have noticed that I use scare quotes when I discuss stem cells in the context of these clinics. That's because it's very much in doubt in most of these clinics whether what is being administered actually consists of stem cells. That's where the need for regulation comes in most acutely. It's also why what is going on in Italy right now is of great concern.

Attacking regulation of stem cell therapies in Italy

It's been a bad year for Italian science thus far. Just last month, animal rights activists broke into the animal facility at the University of Milan and occupied it. During the occupation, they stole animals and rearranged all the cage cards so that scientists didn't know which group of animals were which anymore, rendering their work uninterpretable and ruining years of research. Now this. If you think that the "health freedom" movement is limited just to the U.S. and its more libertarian-leaning groups, think again. The EMBO article, by Bianco et al, starts out describing how this proposed law came to be. Noting that this is the first case in which unproven "stem cell" treatments are recognized as legitimate therapy without having been tested in rigorous clinical trials and based only upon flimsy preclinical evidence, "to be made part of a publicly funded, public health care system,: Bianco et al write (note that "MSC" = "mesenchymal stem cell"):

Patients with disparate, severe neurological diseases were and are being treated, and will continue to be treated in a major public hospital in Italy, by intravenous and intrathecal infusions of ‘MSCs’, purportedly prepared according to a unique, novel method of isolation in culture, and in vitro differentiation into neurons. This activity had previously been taking place in Trieste. In Brescia, an official agreement had been stipulated between the public hospital and a private foundation, whereby the foundation was granted permission to prepare cells with the purportedly proprietary method. Cells for infusion into patients were prepared within a GLP lab (not stringent enough for growing cells in culture before use in patients), intended for the handling of bone marrow and cord blood-derived haematopoietic cells. Patients were being treated in the hospital. Patient care in public hospitals in Italy is paid for by the Government.

More information can be found in these news reports in Nature from March and April. Here's what happened. Apparently, Italy's health minister, Renato Balduzzi, has been impressed by the blandishments and claims regarding adult stem cell therapy and on March 21 decreed that that a controversial (actually, let's be honest, a quack) stem cell therapy can continue in 32 terminally ill patients, mostly children, even though the stem cells were not isolated according to Italy's safety standards. This decision followed a prolonged campaign and media pressure to authorize the compassionate use of the therapy. As noted in this Nature report, hundreds of people protested in Rome on March 23, including a naked woman with pro-stem cell slogans painted on her body.

This particular therapy is marketed by the Stamina Foundation and has been banned multiple times. However, this time the Stamina Foundation has found a winning public relations message, pushing for "compassionate use" of its unproven therapies:

Stamina Foundation president Davide Vannoni, a psychologist at the University of Udine, says that the publicity around the treatment has won him 9,000 new patients. He hopes that further modifications to the law will allow him to expand the therapy.

A month ago, an investigatory television programme, The Hyena, reported that children with incurable diseases such as spinal muscular atrophy were being denied supposedly important treatment, and Italian show-business personalities joined the call to relax rules on stem-cell treatment.

More generally, our findings highlight the risk that the combination of newspaper ‘hype’ and parental ‘hope’, with the support of courts that are sympathetic to families with children with severe disorders, may produce shortcuts in the design of clinical studies that would need more rigorous preclinical information and more accurate safety and efficacy measures and may actually put patients at risk of potential side effects of therapy.

Indeed, I can't help but compare Vannoni unfavorably to Stanislaw Burzynski, who at least has published a few papers and case reports. They might be crappy papers, case reports, and incomplete clinical trials that, when examined closely, don't support his claims, but he has published. Vannoni, on the other hand, seems not to care about even the appearance of not being a quack.

One aspect that Vannoni does share with Burzynski, however, is his willingness to cynically use desperate patients to try to get approval for his unproven therapies. Indeed, public hospital Spedali Civili of Brescia has been permitting the Stamina Foundation to administer MSC treatment for various neurodegenerative treatments, despite its not being one of the 13 authorized Italian stem cell factories. After an inspection in 2012, the Italian version of the FDA ordered an immediate halt to these treatments, and that's when the protests began:

But the halt sparked protests among patients' families who believed the treatment was working. Some appealed to the courts, and as a result a few patients were allowed to go ahead with the therapy. On 15 March, a group of 13 Italian stem cell researchers published an open letter to the country's Minister of Health, Renato Balduzzi, asking him to shut down all of the Stamina Foundation's treatments at the hospital.

The open letter urged Balduzzi not to succumb to the wave of emotion and pointed out that there was no evidence that MSCs can do what Vannoni and his patients' parents claim they can do. They also argued that "compassionate use" exemptions shouldn't be used as a means of weakening regulation of completely unproven therapies. Indeed, it's worth citing a couple of passages, conveniently translated into English here:

The decision seems to be dictated by emotions raised by public opinion rather than by scientifically based reasons. No scientific evidence whatsoever has been produced suggesting that mesenchymal cells may have any effect on those diseases for which it is claimed they could be employed. Moreover, no scientific description has been given of the method by which it is claimed these cells may be obtained. This seems a real subversion of the scientific and moral foundations of medicine, denying both the dignity and the traumatic experiences of patients and their relatives. We are aware of these issues and they profoundly motivate the scientific community to generate and guarantee accepted, visible and public data that will change any potential scientific hypothesis into an accepted curative procedure.

The scientists also addressed the health freedom issue head on:

The freedom of any citizen to adopt any personal health decision, including the wish to refuse any cure, does not imply that the Government is obliged to authorize all medical procedures that anyone may suggest as appropriate. In fact, although the individual choice to use an imaginary or inappropriate therapy complies with the rights of individual citizens, such therapies should not necessarily be approved by the Government and provided by public or private health structures. It is not the Government’s role to respond to pressure from patients to translate an individual choice into a therapeutic option for ready use in any health structure. Media campaigns should not become instrumental in adopting decisions on medical or health procedures. The right of single individuals to adopt snake oil as a freely chosen drug does not mean that snake oil has to be prepared in hospital pharmacies as a result of Government-authorized procedures.

In other words, the Italian government is on the brink of giving free rein to stem cell quacks, but it's worse than that. This order, as the scientists point out, in essence allows government-funded facilities to collaborate with stem cell quacks and facilitate their treating patients.

One point that the scientists didn't really nail, and that's the issue of informed consent. One notes that Vannoni's stem cell quackery has no evidence for it published in the peer-reviewed biomedical literature nor any compelling clinical trial results. Consequently, if claims are being made for this treatment it is impossible to give informed consent because there is no evidence upon which to base even a rough estimate of the chances for success are weighed against the risks of the treatment. Even worse, we don't even know that these are really stem cells. Seriously. As the scientists point out, there is no transparency, and if there's an area of clinical research where transparency is essential, it's stem cell research.

Sadly, the scientists' words fell on deaf ears. In fact, Balduzzi had called a scientific review committee to examine the cases and make recommendations. It recommended against authorizing further use of the Stamina Foundation's stem cells in a public hospital, but Balduzzi ignored the recommendations of his own panel and permitted use of the Foundation's procedure in a terminally ill three year-old. Indeed, not only did Balduzzi sign the order allowing the bogus MSC therapy to continue at a public hospital. On April 10, the Italian Senate amended Balduzzi's ministerial decree with a clause that would redefine stem cell therapy as tissue transplantation, thereby releasing it from any regulatory oversight by the government. If this decree is passed by the other parliamentary chamber in Italy, the Camera dei Deputati, then dubious stem cell therapies will be out of reach of Italian drug regulators. One notes that this will be in marked contrast to European Union and U.S. standards, which treat cells removed, treated, and reinfused as drugs, although sadly one also has to note that the attempt to redefine cell therapies as not being drugs but surgical procedures or "tissue transplantation" is not unique to Italy. Regulations for stem cell therapies are in a perpetural state of catch-up.

It's also hard not to note that the Catholic Church apparently played a role in this scientific debacle. As noted in Nature, Vannoni's stem cell treatments are not embryonic stem cells; they are claimed to be MSCs; i.e., "adult stem cells." Because of its opposition to the use of embryonic stem cells, the "scientifically naive" Vatican is enamored of the sorts of treatments offered by the Stamina Foundation, and indeed even held its Second International Vatican Adult Stem Cell meeting from April 11 to 13, described as "a shamelessly choreographed performance" in which "sick children were paraded for television, sharing the stage with stem-cell companies and scientists desperate to hawk a message that their therapies must be speeded to clinical use" and was framed as a "fight for reason and fairness against an uncaring and intransigent scientific community."

If you go to the Stem For Life website, you'll find a lot of anecdotes, some preclinical science described, but not a whole lot of actual compelling evidence. One anecdote in particular is as manipulative as any I've ever seen anywhere else. Don't get me wrong. I do believe that eventually that stem cells, be they adult or embryonic, will be used for more and more therapies and that they will eventually allow the treatment of diseases that we currently cannot treat, but we have to be realistic and understand what is and is not known about adult and embryonic stem cells before they are used as therapies.

Why the Stamina Foundation's stem cell treatment is highly dubious

All of this brings us back to the EMBO article. I really do have to give the authors credit for a well-written, clear explanation of why MSCs are not ready for prime time yet and therefore why deregulating them, as the Italian government appears to be on the verge of doing, is madness. They pull no punches. First, they argue in a manner that I approve of heartily (and paraphrasing Tim Minchin) that "regenerative medicine must be medicine." In other words:

Stem cells are not a homogeneous class of cells; ‘stem cells’ are not one-size-fits-all cures. There are different kinds of stem cells in different tissues, and even when the appropriate stem cell is selected for an indication it takes years of research to learn how to administer the stem cell safely and effectively, as demonstrated by the decades of research that was required to transplant bone marrow safely and effectively. The use of stem cells in medicine must remain cognizant not only of the true biological nature of the type of cells considered for use, but also of the biology of the diseases being targeted. Treating patients with disparate neurological diseases with intravenous or intrathecal infusion of MSCs, which is being done in Italy, has no medical rationale.

You can tell a lot about a purported stem cell therapy by how the "stem cells" are isolated and administered. If the physician doing the therapy can't tell you what specific kind of stem cells he's using, give a good technical description of how they are isolated and purified, show preclinical evidence demonstrating that they are, in fact, stem cells, and describe how he is going to target them to the correct area, then chances are good that the therapy is dubious. As Bianco et al point out:

In the case of systemic administration of mesenchymal stem cells (MSCs), cells are introduced into the bloodstream, which is not their natural environment. They are infused in the hope that they will reach target organs that do not normally contain MSCs. There is a wealth of knowledge about their function in their natural site (the bone marrow) and a wealth of knowledge on the properties they exhibit in a tissue culture dish. But it is not clear how exogenous MSCs will behave in the brain, kidney, or the lung. As inherently osteogenic and adipogenic cells, MSCs could generate bone or fat in the wrong organs if transplanted in sufficient numbers (Breitbach et al, 2007). MSCs can also embolize in the lungs and damage the local microcirculation. Allogeneic MSCs can trigger an adverse reaction (instant blood mediated inflammatory reaction, IBMIR; Moll et al, 2012), which leads to activation of the coagulation and complement cascades, and to the death of the infused cells. IBMIR can result occasionally in thromboembolism, but we were unaware until recently that IBMIR could be triggered by MSCs. This exemplifies why infusion of MSCs must necessarily be studied in rigorously controlled and monitored clinical trials before such therapies can be considered safe in patients.

In other words, just inject the cells either into the bloodstream or the cerebrospinal fluid, and hope like hell that they "home" in to the right place and know what to do. It's not that simple, unfortunately. Adult stem cell therapy works for bone marrow transplantation because progenitor cells are made in the bone marrow and they tend naturally to stay there when the circulation takes them through the marrow. We also have 30 years of experience using adult stem cell therapy for bone marrow transplantation. Bianco et al recount a little history about this pointing out that the first trial using bone marrow transplant between unrelated patients resulted in the deaths of all the recipients in the trial. Indeed, Donnell Thomas, we are told, spent 14 additional years in the laboratory figuring out why donors had to be matched to recipients before transplant, observing that "This illustrates how even the simplest and most promising cell therapies must be studied in depth to be delivered safely and effectively to patients." He also notes that the situation becomes much more complex for cell therapies in which the scientific rationale for who they might work is not know, unclear, or unproven.

Basically, it turns out that to date there are very few examples of proven stem cell therapies. There is bone marrow transplantation, of course. there are also corneal resurfacing procedures with limbal stem cells and skin regeneration with epidermal stem cells. There is also decent preclinical evidence and a few case reports for bone regeneration, and it is not unreasonable to hypothesize the use of specific types of stem cells for cardiovascular disease, although progress in this area has been disappointing.

Then, as I've pointed out, there's the whole issue of exactly what kind of cell is being used. Just because someone says they are isolating and using "stem cells" does not mean that what is being isolated and used are, in fact, stem cells. Indeed, Bianco et al get almost downright sarcastic (at least as sarcastic as I've seen in a scientific review article) and refer to mesenchymal stem cells as "most suspicious cells," stating:

Cells that have become known as ‘MSCs’ are locally transplantable, system-specific and self-renewing perivascular progenitors of skeletal tissues, including the haematopoietic microenvironment (Sacchetti et al, 2007). They are found in the bone marrow and have significant potential in medicine and unique biological appeal. It is therefore perhaps not surprising that multiple cases of unauthorized stem cell treatments being offered directly to the public before any approval or evidence of efficacy are centred on the use of the so-called MSCs. Lack of scientific rigour, although not unique to the MSC subfield, has flourished therein. Loose definitions and poor assays have disseminated across the scientific community as ‘gold standards’ (Dominici et al, 2006), creating huge confusion and opening the way to the completely erroneous belief that any culture of cells from any kind of connective tissue is a culture of stem cells. The apparent ease of isolation and culture, and the conceptual confusion between a stem cell as a physical and functional entity, and a culture of cells originating from stem cells ex vivo (Caplan and Correa, 2011), have contributed to the widespread use of such cells worldwide. Their nature as ‘adult’ stem cells has granted license and exemption from unwanted ethical controversy. Pressure towards development of therapies from all funding bodies around the world, a general climate dominated by the need to develop treatments (‘translational medicine’, Zerhouni (2005)) and the very existence of multiple companies ready to commercialize ‘MSCs’ have contributed, in turn, to making this particular biological object prone to misuse in the clinic and user-friendly for ill-intentioned salesmen.

This cannot be repeated often enough. Whenever a stem cell clinic claims to be using "stem cells," are they really? What is their scientific rationale? What are their preclinical data? Do they really support the use of these cells? In the vast majority of cases, including that of the Stamina Foundation, the answer is no.

Finally, we should think of these cells in the same way we think of any "complementary and alternative therapy"—or any therapy, that matter—and I have yet to find a better paragraph, even one of mine, arguing for the importance of there being at least a plausible mechanism:

Complementary to empirical clinical trials, a number of studies have been conducted, claiming ‘beneficial effects’ of systemically infused MSCs in animal models. The conceptual design of these studies as ‘clinical trials in a mouse’ is often flawed, detracting from the power of such studies to highlight a robust rationale for subsequent clinical use. Typically, a pharmacological effect is measured, without measuring the dose, kinetics and dynamics of the active principle, unknown at the outset. A putative active principle is often identified ex post through ex vivo reductionistic experiments. These arbitrarily single out a putative ad hoc molecular mechanism out of a maze of possible, pleiotropic, interlocking mechanisms. An arbitrary hypothesis that fits the results is pursued and alternative hypotheses are ignored. In vivo effects are often interpreted in a biased way (e.g., in studies on ischaemic heart disease, size of post-infarct scars is equated to extent of necrosis; effects of cardiac remodelling are ignored). Even though these studies sometimes specifically record the vanishing of infused cells, they fail to relate any claimed effect to kinetics of cell survival. ‘Clinical data in the mouse’ are descriptive and insufficient to offer mechanistic insight. Mechanistic insight is not a dispensable intellectual luxury. It is specifically required to develop effective therapies. It is to this end that we need mechanisms and rationale. MSCs are thought to have a role in treating GvHD and arthritis alike (Keating, 2012), owing to their generic ‘known immune modulatory effects’. The specific immune modulatory effects are not known. We have no way to model and measure them effectively in vitro or in vivo. We have, therefore, no way to distinguish those operating in GvHD from those operating in arthritis, or to tell whether they are the same or different. We have no way to tell whether these effects are unique to MSCs or shared with other kinds of cells, and which ones. While potentially crucial to advance therapies that harness immune modulation, these issues are mostly neglected. Meanwhile repetitive, expensive, small, uncontrolled phase I–II trials with i.v. infusions of MSCs continue to be pursued as useful.

I love two of the sentences in that paragraph; so I will repeat them again: Mechanistic insight is not a dispensable intellectual luxury. It is specifically required to develop effective therapies. Live them. Learn them. Love them. I do, and I try to live by them in my research.

The same admonition could be directed at, say, acupuncture, except that at least MSCs have more plausible mechanisms. However, as Bianco et al point out, preclinical data and understanding are critical to designing clinical trials that can actually give the answer that is being sought. Just taking a bunch of ill-defined cells and willy-nilly injecting them into small groups of patients with wildly disparate conditions with wildly differing mechanisms of disease is likely to be no more informative than taking some needles and sticking them willy-nilly into patients with wildly disparate conditions with wildly differing mechanisms of disease and hoping we'll gain therapeutic insight.

There can be no compassion without safety and efficacy

One of the most potent arguments for Balduzzi's decision in Italy is an emotional one: Look at the suffering children! They are dying! How can we possibly deny them this therapy? My response would be to rephrase that a bit by adding specific therapies other than stem cell therapies.

For example: Look at the suffering children! They are dying! How can we possibly deny them MMS enema (bleach enema) therapy?

Or: Look at the suffering children! They are dying! How can we possibly deny them homeopathy?

Or: Look at the suffering children! They are dying! How can we possibly deny them bloodletting?

Sounds ridiculous when put in those terms, doesn't it? But, even though some day they might turn out to be wonderful treatments, right now stem cells are in the same boat. We do not know if they are effective and safe, and there is an incredible paucity of preclinical evidence to show that they do anything for the deadly diseases for which they are being used in Italy. The argument is that these severely ill children have nothing else going for them, no other therapeutic alternatives; so safety concerns can be thrown out the window. However, terminally ill patients need more safety and protection, and exposing them to unknown risks in a therapy with no evidence of efficacy is, as Bianco et al, put it, ethically unacceptable. Most people would accept the contention that someone who is severely or terminally ill has the right to take risks in search of treatment, but their willingness to take such risks because "they have nothing to lose" makes them vulnerable to any number of unproven treatments or even outright quackery. Without some sound evidence that a treatment might be effective, they are in essence taking all risk with at best an unknown and likely very small chance of benefit and at worst no benefit at all for all the risk. While personal freedom might give them the right to "roll the dice" and take large risks for minimal chance of benefit, neither physicians nor the government are obligated to facilitate their taking such risks. In fact, quite the contrary for physicians, who are ethically bound to give proper informed consent and obligated not to provide treatments without evidence of efficacy. As Bianco et al put it, "There can be no compassion without safety and efficacy."

One can only hope that the Italian government figures that out before the Camera dei Deputati takes up the minister's decree.

More like this

I've frequently written about bogus stem cell clinics that use hard sell techniques to sell unproven and expensive "stem cell treatments" to desperate patients. For instance, I deconstructed the story claiming that hockey great Gordie Howe improved so markedly after a severe stroke, thanks to stem…

A week ago, I wrote about a naturopath in Utah named Harry Adelson, who was advertising his use stem cells to treat lumbar and cervical disk problems, including degenerated and dehydrated disks. That alone was bad enough, but what elevated "Not-a-Dr." (my preferred translation of the "ND" that…

Last week, I wrote about a man named Jim Gass, a former chief legal counsel for Sylvania, who had suffered a debilitating stroke in 2009 that left him without the use of his left arm, and weak left leg. He could still walk with a cane, but was understandably desperate to try anything to be able to…

Houston, we have a problem.
Oh, wait. I'm not talking about Stanislaw Burzynski this time. But we do still have a problem, and it's a problem that resembles the Burzynski problem I recently discussed. Specifically, it's a problem of unethical clinical trials somehow winning approval from…

One is known as “fresh cell therapy” and involves harvesting cells from lamb fetuses and injecting them into the patient.

Those cells aren't "self"; they arent even human. Why would one expect the body to do anything other than kill them off as fast as possible, without giving them the opportunity to do whatever magic stem cells are supposed to do?

Back to the topic at hand, I think we're seeing a version of the CSI effect here....that people have been shown the "miracle" of stem cells in various sci-fi drama, that they believe that injecting anything that says "stem" in the title will perform some type of magical mystery cure......regardless of the disease treated.

Just look at shows like Fringe, for example, that make "weird" science palatable....and for the gullible, raised expectations that this type of Science was real & could be utilized. Scary stuff that people can be so stupid.

The status of Vannoni's therapy is even worse than Orac states in the post. From the March report in Nature:

Some of the compelled treatments led to the only publication of clinical results so far. Clinicians at the Burlo Garafalo Children’s Hospital in Trieste treated five babies with type I spinal muscular atrophy and published the results last October (M. Carrozzi et al. Neuromuscul. Disord. 22, 1032–1034; 2012). They found that “the treatment did not change the course of the disease”, says co-author Marco Carrozzi. Vannoni argues that the therapy failed because the clinicians did not use his exact cocktail of cells.

So there is a publication showing Vannoni's therapy to be useless (at best), though Vannoni claims that it was the physicians rather than the treatment that failed.

Italy had parliamentary elections since Balduzzi issued his decree. He's no longer Health Minister, and I haven't heard whether he stood for election this time around. I also have heard (but haven't been following this too closely) that there has been some difficulty forming a coalition government following the elections, which may be why the Camera dei Deputati has not taken up this legislation yet.

There's a radiologist in Alabama purporting to "cure" ALS by harvesting and isolating MSCs from adipose tissue from the patient in question. These are then reinjected into the spine where they apparently go on to repair the degenerative motor neurons. Because...magic? Unfortunately I have a relative who fell under the spell of this junk and is now $20K poorer and in end-stage ALS. There isn't an appropriate term I can use to express my disgust for people like this.

Driving home yesterday I was surprised to see a local Hair Restoration Clinic now advertising (on a billboard) stem cell therapy. In the car we were joking how the doctor on the sign had missed the boat, here she'd make a breakthrough with stem cells and didn't think to try to apply it to organ failure or Parkinson's Disease.

But it was also kind of ominous. The words "stem cells" now have so much cache with the general public that anyone hawking a product of any sort is trying to work those words into their billboards. Quack heaven.

Dachel well and truly shoots herself in the foot with this comment on the video. After offering the rhetorical question whether "Wakefield's work stopped Hilleman from getting the Noble [sic] Prize for Medicine," one finds in the NYT article that Hilleman "got hate mail and death threats instead."

Little wonder she generally limits her "professional" public exposure to cut-and-paste spamming.

Two facts about Vannoni's "therapy":
1) The true, huge step for Stamina Foundation was to go to Spedali Civili in Brescia, one of the best public hospitals in Italy. There are rumors that the first name in the list of patients treated with stem cells wasn't a child but a local politician. Put together with the fact that in Italy healthcare is supervised by regional (local) governments.... Sadly, privacy law doesn't allow to know the name, so, take it as a mere rumor;
2) Vannoni has tried to patent his "therapy" in Usa (2) and in Italy (2), but his requests were rejected due to lack of "originality", at least in Usa, with this words "The claimed invention, as a whole, is clearly prima facie obvious".

Thank for the post. I hope that my country will not become the Land of Quackery....

Sitting here feeling like dog vomit because the fibromyalgia is playing up again (what is it with Tuesdays?) I can understand why people with chronic illnesses, or kids with chronic illnesses/disorders, fall for stuff like this. Which makes me all the more angry at the snake-oil salesmen who peddle this garbage.

Ah more stem cell quackery. Seems to be the same old MO. Promise to cure a hard to treat condition with an unevidence-based treatment, claim that Big Phama or the Medical Establishment is trying to hide the evidence for the cure to protect their income streams, and watch the money roll in from desparate patients.

In other news Greg Beattie, new President of the AVN, has stated parents should not trust their doctors about vaccines, but get their information from "health professionals who maybe aren't in the medical mainstream''

@Dangerous Bacon:
I would like to remember you that no-one from other countries has ever commented on any post on Burzynski with "Well, it is the US, what can you expect?"
Because most people understand that idiocy and greed are humans trait, same everywhere (and pretty much in the same percentage).

"[I]t is not unreasonable to hypothesize the use of specific types of stem cells for cardiovascular disease, although progress in this area has been disappointing."

Not sure what you mean by disappointing. There have been several small randomized trials, most of them positive. I found an Italian review from 2007 (Giordano et al., Journal of Cellular Physiology 211: 27-35) that cites three studies in which MSCs improved ejection fraction in people who had had myocardial infarctions. There's been at least one more placebo-controlled study to report the same since, as well as a few studies comparing different methods, and an American study was being set up in 2011.

That's critical, of course, because one of the tenets of American scientism is that everyone else is "behind" America, or at least behind the Anglophone world - sometimes, it's hinted, so far "behind" that they should stop trying to innovate and just do what we say is good. Whenever others accept a practice that we do not, it's got to be either obsolete or unproven, because we are always the most knowledgeable judges of what Science has to say. That was once true, I think, at the peak of our empire - but it's not true anymore. Science as a body of knowledge is now too broad and deep for any one nation to dominate in every area of research, and America has not been pursuing advancement of knowledge as well as possible lately. In some fields, other nations have already surpassed us, and that will continue to happen in more and more fields.

The studies of MSCs for heart disease are still all too small to put much weight on, to be sure - but if this method did continue to show benefit in larger trials, it would go mainstream first not in the U.S., but in Europe, where far more relative effort is being put into this research. At that point American thanatophobes would have their choice of continuing to sneer at the benighted Eye-talians or going abroad, hat in hand, to buy treatments that America hasn't gotten around to figuring out how to use yet. And that seems like just deserts for a scientific establishment that purports to be above culture yet refuses to accept or learn from any work done abroad that clashes with their cultural beliefs. (Like acupuncture studies - but that's a different issue.)

That’s critical, of course, because one of the tenets of American scientism is that everyone else is “behind” America, or at least behind the Anglophone world – sometimes, it’s hinted, so far “behind” that they should stop trying to innovate and just do what we say is good. Whenever others accept a practice that we do not, it’s got to be either obsolete or unproven, because we are always the most knowledgeable judges of what Science has to say.

Ah. That must be why we don't have the measles, mumps, rubella or varicella vaccines, which were developed in Japan. Oh, wait.

Todd W - Nice, if slightly bizarre, try at using the MMR vaccines as a synecdoche for all medical innovation past, present, and future. Did I say America was never the world leader in medical science? No, at one point, indeed we were the tops - which does NOT mean that everything then being done in Russia or France, say, was automatically worthless. The MMR vaccines, all several decades old, come from that era. Now, sorry, those days are long gone. It is a multipolar world and you cannot sit on your butt and assume that the rest of the world is too culturally inferior to have and develop a genuinely valuable idea that one of our scientists or megacorps has not already had. Or rather, you can, but that will only hasten the decline of American dominance. The more groundbreaking work that is published by Italy - and yes, Japan! - the less foreign doctors and American patients will feel obliged to fawn over American opinion molders.

By the way, when Science is used as a sockpuppet to dictate that disliked results of actual scientific studies should be automatically ignored, I think it is entirely fair to say that what you have there falls into the category of a civil religion. In the mouths of its preachers, it presumes to dictate values, for one thing, which science-as-process can never do. It presumes to say not only that questions that can't be answered by the scientific method have no value, but that some questions that could be answered should not be allowed to be asked. It presumes to say that published scientific data should be treated as garbage or fraud if they do not fit with certain pre-existing beliefs, or that certain beliefs must continue to be held as likely even as data to oppose them have been amassed. These are dogmas. Just as for theistic religions, there are different branches of scientism that vary in the breadth and stringency of their doctrinal requirements. (For example,a few people on other blogs seem to think Science demands that we continue to assume that animals are automata who do not think or feel, never mind all that silly neuroscience and animal behavior research. People around here seem to emphasize mostly that any medicine not recently invented in the Anglophone West must be worthless, so shut up about those clinical trials.)

@Jane - you missed Todd's point that plenty of drugs and treatments from overseas are currently in use, not just here, but worldwide.....what counts is the actual scientific backing of whatever is being presented. In this case, in Italy, the science is very lacking.

It has nothing to do where a particular treatment originated, but if it is actually effective.

you cannot sit on your butt and assume that the rest of the world is too culturally inferior to have and develop a genuinely valuable idea that one of our scientists or megacorps has not already had.

Perhaps you missed the point of my comment. I was illustrating that we do not assume scientists from other countries are inferior.

As for the rest of your comment, wow! What a massive flaming pile of strawmen. You have some citations to support your wild claims that scientists think anything not from the "Anglophone West" must be worthless or that results of studies are automatically ignored simply because the results are not liked?

You have some citations to support your wild claims that scientists think anything not from the “Anglophone West” must be worthless or that results of studies are automatically ignored simply because the results are not liked?

Because if that were really true we would not have either the varicella or DTaP vaccines, plus some other treatments.

Lawrence - Since I was quite sure that at least two of the measles, mumps and rubella combo were invented by Americans, I presumed he was being sarcastic in saying they were Japanese. He indicates below your comment that he was serious. Chris adds that the DTaP vaccines (what we used to call DPT) are also of foreign origin. Checking Wikipedia, I find:

Measles - first vaccine 1963, US
Mumps - Currently used Urabe strain is of Japanese origin (and associated with higher meningitis risk, hence already abandoned in some other countries). But the U.S. had a killed vaccine version starting in 1950, and then a Merck-made Mumpsvax.
Rubella - Seems to have been first used as part of the MMR combo created by an American working for Merck.
Tetanus - First tetanus toxoid put into use by a French scientist, following early basic research by Italian and Japanese scientists. Since superseded.
Diphtheria - Pioneering work in 1890 by the same Japanese guy and a German guy; only the German got a Nobel out of it. Americans started producing antitoxin within a few years based on his work.
Pertussis - First vaccine developed by an American, followed quickly by a Dane; DPT mixture created by an American woman; safety was improved by a Japanese scientist in 1981 (in Japan, approved in the US 11 years later).

So maybe we can give Todd W. half credit. When he listed off a bunch of vaccines that were not made in Japan he mightsimply have been thinking of the wrong acronym, MMR vs DPT, since Japanese science did in some way influence all three vaccines in the latter. One does get the impression that the early work would have been done here not much later if necessary, since back around 1900 there was considerable research interest in vaccines. So it might be a stretch to say "we would not have" tetanus vaccine.

As for whether the science on stem cells is lacking now, yes. I sure wouldn't pay money for them. But! It seems that there's now more European science of the randomized human study sort and *published in journals* to back the use of these adult stem cells for a couple of conditions than there was American (or phonied-up South African) science in favor of bone marrow transplants for breast cancer, which some emdees (not, glad to say, our host) got quite rich dishing out. I doubt that the stem cell treatments can be killing so high a percentage of patients as that treatment did. Traditionally, the introduction of novel procedures has been done with far less regulation than the introduction of new drugs, which is ethically questionable since a patient has no power to reverse a procedure with unacceptable side effects. (Google "endometriosis" and "rectal pull-through" if you want to ensure that you never consider consulting an allopath for a gynecological problem again.) Orac implies not just that the institutions offering stem cells in Italy are using inadequately strict ethics, but that the government should shut them down. Should the U.S. government have shut down the whole bone-marrow transplant catastrophe at the beginning? If we are to prate of ethics, there must be universal standards.

Mumps – Currently used Urabe strain is of Japanese origin (and associated with higher meningitis risk, hence already abandoned in some other countries). But the U.S. had a killed vaccine version starting in 1950, and then a Merck-made Mumpsvax.

No. The one used in the USA is the Jeryl Lynn mumps strain that became available in late 1960s. The story is in the New York Times today.

Quickly as I haven't time to be involved in this: no-one is suggesting shutting down all of stem cell research or all stem cell-related businesses.

It is unethical and poor practice to allow people to tout and sell things that have not (yet) being shown to work, especially if they might adversely affect others.

There are a number of ‘clinics’ making what to be polite are rather unlikely claims about treatment using ‘stem cells’. It’s fair and sensible to ask that those ‘clinics’ show their claims have substance before offering their products. Aside from the science aspects, there’s the issue of unsubstantiated claims in advertising.

That’s critical, of course, because one of the tenets of American scientism is that everyone else is “behind” America, or at least behind the Anglophone world

For anyone with training in the physical sciences or mathematics, this statement is a knee-slapper. Not too ago, reading competence in German, Russian, or French was mandatory for completion of a Ph.D. in such fields. But...

Now, sorry, those days are long gone.

Amazingly, there is a whole field of scientometrics. I quick survey does not suggest that the broad brush of "scientism" is much in evidence (for a look at Russia, see here [PDF]; following the references to Zitt is of some interest). Indeed, what do people who use this word with some care think it means? Here (PDF) we find an epistemological quarrel over a critique of the term. Jane's "American 'scientism'" is nowhere in sight. The question to my mind is where this novelty comes from.

Yep, I was going from memory and got my Japanese-developed vaccines wrong. My point, however, was that there are medical products and procedures that have been developed by non-Western scientists that are very well-accepted in the U.S.

Jane, your blanket statement that American scientists dismiss anything that isn't "Western" is false. (By the bye, I believe that Italy is considered to be part of "Western" culture, so your argument makes even less sense.)

You're also engaging in a tu quoque fallacy by bringing in the bone marrow transplant stuff.

Back briefly to the Wakefield video comments, Slivermaven has checked in with this compound factual error:

The only fraud ever conducted was by phamaceuticals who failed to tell you that HeLa cells came from a woman who had Syphilis, and that spirochetal prion proteins cannot be killed. They recombine with what ever junk DNA they want to survive. SHAME is upon the medical mafia killing the public on purpose for lies of protection that never worked and only destroyed our immune systems forever more! Because they refuse to stop adding to the mix!

.[redacted]/releases/2013/5/prweb10694837.htm

This press release is gone, but it lives on in the Google cache. Too bad that Charles E. Holman Foundation failed to note that F1000 Research isn't a journal, much less "prestigious."

Narad and Todd W - You keep on conflating science and scientism; I suppose that I should have stepped on that right away when you started mentioning vaccine science. I never said that practicing American scientists rejected research published by foreigners. In my field, as in many others, workers from any country are given equal respect for similar work. My impression is that those online proponents of scientism who claim that Science requires us to hold certain beliefs, and immediately reject studies that question those beliefs, are usually NOT professional scientists. Those people have never spent much time at international meetings listening to presentations of significant work by nonwhite people with funny accents, so it is easy for them to say "Oh well, that's Chinese; you can't trust anything that's done in China." (Or "It's Italy, Orac.")

Todd W - No, asking about bone marrow transplantation is not the tu quoque fallacy. One of the things that annoys me most about the high-school debate model is that people think they can say "Oooh, you said a Fallacy!" and they have won the entire argument without even needing to demonstrate that their charge is true. Better yet, you can put the name of the alleged fallacy in Latin to better cudgel the lower orders into submission; they can't point out that your charge is false if they aren't sure what it means. While most real fallacies can be shown to be such as a matter of objective logic, the "tu quoque fallacy" seems to me almost uniquely vulnerable to selective usage based on status and group affiliation. To say "It's okay for Sue to do X because everyone agrees it's okay for Fred to do X" is not obviously false, except perhaps to Fred; it deserves an answer, not a sneer. As it happens, I didn't say that; what I said was more like "If it's wrong for Sue to do X, wasn't it also wrong for Fred to do X but even worse?" If you agree, all you have to do is say "Yes, and Fred shouldn't have gotten away with that, but now both Fred and Sue should be discouraged from further such acts." If you don't agree, then there is a very substantive question - in this case, how one can decide which novel invasive procedures should be illegal for clinical use, which should be legal but called unethical, and which are just peachy; whether the rules should be the same everywhere; whose values should be used in setting the boundaries - that would be worth discussing.

You keep on conflating science and scientism; I suppose that I should have stepped on that right away when you started mentioning vaccine science. I never said that practicing American scientists rejected research published by foreigners.

You did come in with vague accusations of scientism. One could easily assume you were painting with a broad brush and accusing people of scientism who were not engaged in any such thing. Now, you have narrowed your focus (slightly), but you still suggest that certain commenters are worshippers of scientism based on one or two comments, rather than looking at their overall behavior.

As for the bone marrow example, to me, it read as if you were saying that we should go easy on the Italian stem cell clinics because bone marrow transplants were so poorly regulated when they were introduced. I don't know if I was alone in that reading of your comment, but that's how it sounded to me.

Finally, you take one person's comment that was, admittedly, very vague and could be taken in multiple ways, as evidence of scientism, suggesting that things are being dismissed simply because "It's Italy". Here's another interpretation: based on the current scientific and political climate in Italy (i.e., active hostility toward actual science), we should not be surprised that there is more anti-science or pseudoscience coming out of there; certainly look at it, but look with a grain of salt and additional scrutiny.

Similarly, people do not dismiss out of hand research out of China. Rather, based on past evidence of research misconduct, studies are looked at more closely and critically, because there is valid reason to be concerned there may be additional fraud. The same applies to research coming out of American or Western European labs that have a less than stellar reputation. If these studies were simply dismissed without any other consideration, then Orac and others here wouldn't even bother reading and analyzing the studies.

Getting back to your accusations of scientism: Who is engaged in that? What is your evidence to support your claims?

@jane - I don't see anyone making blanket statements that "research done around the world is garbage & shouldn't be trusted." What I see if a desire that all research, regardless of where is comes from, should meet the same high standards of peer-review and replication - and in areas where there have been legitimate areas of concern (like China, for example, where rampant publishing fraud has been proven), extra scrutiny is necessary.

For the post above, there isn't even published Science to show that this particular treatment is effective (and what little is known, it is completely ineffective) - that isn't because it is coming out of Italy, it is because it is junk science coming from a Quack. I don't care where the quack lives - bad science is bad science.

Lawrence - I don't know anything about the quality of that one clinician's care. Most of the guys who gave bone marrow transplants weren't publishing any research on it, so his failure to publish in itself doesn't make him a Quack. However, I have no opinion as to that guy's competence or ethics. As for the quality of the science that is being published, well, it's not my field so I can't be sure. However, I would not a priori assume that Italian science was of worse quality than American science, where the biggest of the big money reigns supreme. Orac's statement that research on stem cells for heart disease has been "disappointing" specifically does not seem supportable so far, unless you assume that published postive results from multiple researchers must be of such bad quality as to be worthy of rejection. And that is a belief that requires an explanation.

jane - I don't speak for Orac, but "disappointing" is a relative term. Perhaps he hoped for stronger positive results earlier. He may interpret the results differently than you do. Maybe the most recent data he reviewed didn't include some of the studies you list. Why do you assume he meant that the studies were worthless because they were not done by English speakers?

I can't assume that he means that, though he's not immune to the attitude that foreign work may be regarded with extra suspicion to a degree correlated with his dislike of the results. But it's not clear what he does mean. To me, when most studies of a treatment for a given use, including the apparently "best", give favorable results, this might be better described as "promising" than "disappointing". Stem cells are a recently invented, hi-tech modality; if enough evidence is amassed for their use to make that use mainstream, they will be solidly within the scope of conventional medicine, not traditional nor alternative medicine. It is thus a little funny to see favorable studies being dismissed as if some people "just know" that stem cells can't really work in the same way they "just know" no traditional modalities can really work. And that is what makes me wonder whether those people would have had a more favorable attitude if it were American research teams making most of the progress. The most obvious alternative explanation is that, as for the hostility a few people seem to have towards research on gut flora, they just don't like to see anything gaining attention that they weren't taught in school. Or possibly these people have such a deep understanding that they know why all the favorable studies will prove to have been wrong, but they can't explain it to the rest of us.

I never said that practicing American scientists rejected research published by foreigners.

Well, you did say this: "By the way, when Science is used as a sockpuppet to dictate that disliked results of actual scientific studies should be automatically ignored, I think it is entirely fair to say that what you have there falls into the category of a civil religion. In the mouths of its preachers, it presumes to dictate values, for one thing, which science-as-process can never do."

Which is to say that scientists, who you are claiming not to be guilty of the "scientism" that you are apparently reporting from a disadvantageous orientation in Plato's cave, are nonetheless its high priests.

However, I would not a priori assume that Italian science was of worse quality than American science, where the biggest of the big money reigns supreme.

Aside from one flippant comment, nobody here is doing that. Perhaps you'd also like to quantify "the biggest of the big money reigns supreme." Are you referring to the split between governmental and private-sector funding? You could have made that case (but didn't bother to), and you would still have been stuck with the "reigns supreme" part.

Instead, we get this low signal-to-noise ratio rambling about an increasing idiosyncratic version of "scientism" -- which, apparently, is now down to "American lay 'scientism'" or something -- that has very little bearing that I can see on thoughtful uses of the term.

jane,
I can’t assume that he means that...Yet that is what your messages, including this last one, says you do. If you really hadn't assumed that Orac (and others) were dismissing foreign research out of hand, I'd like to think your message would have been more along the lines of "I have to disagree that the current research on treating heart disease with stem cells is disappointing. If you look at study a, b, and c you'll find ...".

But no. You decided to use the term "scientism" (I'm unclear on what that is supposed to mean, but I presume it's not complimentary) and to accuse people of attitudes that you can't reasonably prove they hold.

You decided to use the term “scientism” (I’m unclear on what that is supposed to mean, but I presume it’s not complimentary) and to accuse people of attitudes that you can’t reasonably prove they hold.

She sets it out here. It's a mishmash that never seems to get provided any sort of philosophical grounding. She's been trotting this out at SB since at least 2010, always with same result: that she has nothing but vague complaints and never seems to tie them to anything in particular, even though she presents herself (vaguely, again) as a scientist and probably has "more of a clue about how to conduct research than you do."

Heh! I will just offer one more short response to all the personal comments at once, viz: People who are actually doing [most kinds of] scientific research, are in my observation, usually not the people who serve as aggressive proponents of the sort of worldview that many term scientism. I think this may be because most of us comprehend the limitations of our own fields well enough to see the wisdom of humility on the broader scale.

I find it hard to reconcile your remarks about ‘non-white’ or ‘foreign’ scientists and biological research (or for that matter research in any area of science): so-called ‘Western’ research labs are full of people from all over the world, with different cultural backgrounds too.

I never said that practicing American scientists rejected research published by foreigners.

"Never said" is a strong claim that invites us to look back at earlier threads:

And finally, there certainly is a pro-Western (or pro-American) and anti-Asian bias among some followers of scientism – it has shown up nicely in the tai chi thread. [...] But when Asian results conflict with American results, or when Asians study something Americans haven’t studied and the results don’t fit with the dogmas of scientism, they are often immediately dismissed as being presumably of low quality.

Perhaps the intended inference here that the unnamed anti-Asian scientismists cannot be true Scotsmen practicing American scientists, by dint of their bias.

#59 crossed over #58. #58 is a little better, but then why all the earlier stuff? (Perhaps you set aside your comments for a few minutes before posting them, so that you might see how they read to others.)

Consider if scientism is largely a strawman created by those that oppose science as a device to foist onto and frame those they oppose. By contrast at different points you have scientism as not real (not how science is) and also real.

Ha-ha-hah, hah-let me get my breath.
Take a biology course, ma'am. Stem cells are not a recent invention-using them is-, but they've always been around. (Seriously, are babies, as a whole, a recent invention?) They are not more high-tech than any other kind of cell. The only thing that is different about them, as far as I understand, is that they can, eventually, become another form of cell. Like for instance, you can turn a stem cell into a liver cell, but you can't turn a lever cell into, say a lung cell. Capiche?

The thing I find most interesting about stem cells is that they appear to be part of an innate repair mechanism that doesn't work as well as it might. Our bodies apparently have the required mechanisms to repair a heart damaged by ischemia, or to regrow a severed limb, so why don't they? Or is that a dumb question?

Krebozien: My personal theory is that it might have to do with the energy cost. Perhaps a vertebrate burns too much energy regrowing a limb or organ to make it worth the trouble? I think the only vertebrate that grows back something are certain sorts of lizards, and even then tail regrowth is very slow. (But it presumably is worth it to the lizard.)

And that seems like just deserts for a scientific establishment that purports to be above culture yet refuses to accept or learn from any work done abroad that clashes with their cultural beliefs. (Like acupuncture studies – but that’s a different issue.)

I'd say that the delicious irony is pretty much the exact same issue, given that acupuncture was only saved from the honey wagon by means of a "Western" importation.

I think the only vertebrate that grows back something are certain sorts of lizards

Salamanders and other amphibia are the experts. Of course amphibia have to rebuild their bodies completely with the whole metamorphosis thing, so they *have* to be good at it.
Tuatara -- who are not lizards -- can also regenerate tails.

Speculating wildly, I imagine that a mammal that loses a limb is very likely to be eaten by a predator during the regeneration period, which would dramatically reduce the evolutionary advantage that such an ability would endow. A lizard sans tail would still be able to run away from something trying to eat it.

My name is Dr. Javier Lopez, President of the Regenerative Medicine Institute in Mexico, all bloggers are more than welcome to ask any questions regarding the validity of our program. It is said when people use these forums to cite certain information that they cannot back up in any way shape or form. RMI complies with all Mexican Health Code as well as FDA Regulations regarding stem cell research. I wish we all do our due diligence before posting false accusations. http://clinicaltrials.gov/ct2/results?term=stem+cells+and+ageless

I am discouraged that in the year 2013 we are having this "hocus-pocus" conversation regarding the validity of adult stem cells. I am a freelance writer who has spent the past two years interviewing and writing about patients who have taken part in the clinical trials at Regenerative Medicine Institute, Mexico.

As a professional writer for 25 years I have amassed clients of all kinds. When Dr. Lopez asked me to look into the current well-being of prior patients I was, at best, skeptical. I made it clear that the first time I suspected deception of any kind I was done.

I sincerely undertook this assignment with the critical eye of a longtime reporter. I expected (wanted perhaps) to find people who called it a sham. After conducting two years worth of interviews I can tell you that those patients lives have been changed. People who should have been dead years ago are thriving.

Are they all back to their teenage selves? No, What they have achieved is quality of life. To my knowledge, none of them suddenly spoke a new language or learned to do back-flips, but that wasn't what they were looking for. All they asked for was a chance for the healthy adult stem cells in their bodies to have the opportunity to heal the diseased areas.

Other than one very troubled girl who has posted negative videos about her time at RMI (which, by the way, she promises to remove for a large fee), the patients I have interviewed say they would trust Regenerative Medicine Institute, Mexico in a heartbeat.

I'm not sure if you are aware, but RMI is the chosen test site for Bioheart Inc.'s ANGEL TRIAL, a Phase 1 study to determine the safety and effects of adipose derived stem cells in patients with chronic heart ischemia. This is an FDA approved trial.

Prior to making any blanket statements about a hospital, clinical trial, research scientists, or physicians dedicated to finding a new, better way to help the body heal, perhaps you should do your research. Schedule a visit. Speak with former patients. Do SOMETHING other than write uneducated pieces designed to incite a reaction.

One might wonder why Dr. Perez popped by in the first place, leading to a quick mop-up action by a paid PR flack. Anyway,

Other than one very troubled girl who has posted negative videos about her time at RMI

As Dana didn't see fit to identify the "culprit," her site is here. One may refer to her as "disturbed," something that a "longtime reporter" (i.e., a few years writing fluff pieces in Podunk years ago) might have learned to be cautious of from the AP Stylebook, but I see no particular reason to dispute the account of an immediate attempt to solicit a testimonial.

Perhaps Dana, now that she has clumsily attempted a preemptive action where none was warranted in the first place, would like to discuss this matter in a bit more detail.

Dana has also written a glowing piece about the RMI in a rag called Medical Tourism magazine, which features puff piece advertorials designed to lure Americans to Mexico, Costa Rica, Columbia, China and other countries to treat their medical issues.

...I can tell you that those patients lives have been changed. People who should have been dead years ago are thriving.

Prior to making any blanket statements about a hospital, clinical trial, research scientists, or physicians dedicated to finding a new, better way to help the body heal, perhaps you should do your research. Schedule a visit. Speak with former patients...

The comments on here raise a lot of important questions and exemplify in action some of the tricks of the trade.

I am myself a stem cell researcher and blogger.

The stem cell field has a real problem on its hands with scads of dubious clinics sprouting up all over the world including in the US and in Europe (I'm surprised no one has mentioned Xcell, where a baby died and which at one time was the largest stem cell clinic in all of Europe before it was shut down).

The US has big problems too with rogue clinics that don't even make an effort to pretend to be FDA compliant.

In my opinion, no matter the location, clinics aiming to really help patients rather than just line their own pockets with cash have some traits in common: they publish their work, they follow the laws of the day even if they disagree with them and are working to change them, they properly consent their patients as to risks, they do not charge patients to participate in clinical trials, if they grow cells they use GMP conditions, they follow up on patients for years after treatments, they do not verbally attack former patients who have concerns, they do not make unsubstantiated claims about safety or efficacy (e.g. "lives were changed"), they educate themselves & their patients about stem cells and regulatory issues, and they advocate for transparency (e.g. publishing patient consent forms, etc).

Of course not even the best good citizens of the stem cell commercial world do all of these things, but these are goals to aspire to and some do a very good job overall.

Why did Dr. Lopez pop up with this: "RMI complies with all Mexican Health Code as well as FDA Regulations regarding stem cell research. I wish we all do our due diligence before posting false accusations."

I read the whole comment thread but didn't see a single mention of his clinic or even of Mexico before he popped up. Did I miss something?

Have I received a paycheck for interviewing and writing about patients? Yes. It's what I do for a living.

Does that change my opinion as to what they're telling me? No.

Unlike many people, I am not for sale. Because you don't know me I will forgive your ignorance. I have been writing for a very long time, have sniffed out my fair share of scandals, and have made enemies along the way. I wouldn't lie for one of my children, much less someone I have been hired by.

Seriously, what is so difficult about speaking with former trial participants yourself? To make any proclamation without credible evidence is dangerous. Ask those people who claim that their lives have been saved. It may change your perspective.

I believe that there are clinics out there that scam, make promises they can't keep, and otherwise take advantage of people when they are at their lowest. All I'm saying is that from everything I have seen and heard these past two years Regenerative Medicine Institute, Mexico is one of good ones.

Choose to believe whatever you want, but don't be surprised if the day comes when you need adult stem cells and they're not available to you due to this kind of short-sighted gossip mongering.

The clinical base is established by research which is foundational to good clinical practice. Research and Science are REAL . They are part of the process so we can get evidence into practice and all patients can benefit rather than only the private pay public who are well enough to travel offshore for treatment. The saddest part of the article for me was when the contributions of the scientists were marginalized to make way for marketing.

Treating professionals enter into a trust relationship with patients. For this reason shared decision making is not equal because the physician has the balance of power, knowledge and the position of trust. Patients are vulnerable and will spend all to get well. Physicians need to be aware they have a duty to honor this trust. Speaking of someone with failed treatment as troubled etc is not in their best interests and is blaming and not problem solving or protecting the vulnerable.

Given these clinics thousands of paying patients one would think they could consider putting a small percentage of the money they make from each patient's illness and the intervention of choice into a fund to conduct research trials that are worthy of regulatory approval so future patients can be assured of evidence based efficacy, safety and enjoy the security of their insurance approving the intervention? Perhaps they could hire research scientists to collaborate with you. I can understand the young woman on Youtube who posted all her medical records showing the lack of efficacy offering to take the videos down for compensation, her treatment was costly and the stress of bad treatment, being called unstable/troubled and the betrayal of trust is beyond any monetary price.

It is important to consider that research is NOT an intervention. Scientists should not be expected to be treating physicians nor treating physicians to be scientists. If they choose to wear both hats then it is only fair that they abide by the regulatory constraints for BOTH out of respect for patients, society, science and medicine.

I think using rule of rescue in the way that has been done here is disrespectful to scientists and implies scientists are the with holder of treatment while non-compliant vendors are the benevolent provider to patients. Do you think scientists have faced no battles and that innovation is possible only by physicians who scorn regulation and have not been trained in this field?

I hear so many claims that research and safety is already established. When I look them up the treatments are not the same as the vendors offer and the research is sometimes poorly done, there is evidence of bias and the evidence is weak. Precision and accuracy are called for. Where is the sensitivity analysis for your evidence along with numbers needed to treat and an appropriate randomized trial with treatment against best existing standard of care.

With a treatment so effective by their reports it surpasses all other contributions and should make medical history or at least change the practice of medicine. With this kind of success there is no need to attack Big Pharma duplicity and sedition against the FDA.

Just do the trials and the stopping rule (treatment is overwhelmingly effective and it would be unethical for the trial to continue as uncertainty is not present and all controls can be offered the active treatment) will take over for a wonderful happy ending. For explanation of the importance of registering trials and reporting data http://www.ithinkwell.org/open_data_better_care/

If on the other hand you are reading this as a victim and have been harmed by non-compliant stem cell providers there is a simple FDA criminal report anyone can fill out. http://blogs.fda.gov/fdavoice/index.php/2013/04/fdas-criminal-enforceme… .For those that are passionate about the benefits and feel regulatory restrictions are unfair why not engage directly with FDA and members of congress. There are multiple events offered at no charge where the public can hear, meet people face to face and be heard. Would you like trials to be faster, cheaper and research compassionate clauses expanded? Find out the barriers and problem solve together.

COI: As a stem cell naïve individual recovering from serious trauma I wrote for an outfit that promoted non-compliant stem cells. I had no idea what they were promoting could do harm. There are many good people who have been used to run foundations ,operate labs, write, give complementary medical care, or do other media blitzes along with stem cell promotion and they know nothing except to do a good job for the 'boss'. They are caught in the cross fire…nice people in the front office unaware of the need for science.

You also do know that ancedotes do not count as actual evidence. Sure, anyone can say that such a treatment may work, but how can we tell if a person is lying, is being pressured to make a statement, etc.?

That is why we are looking for evidence, not just stories.

Where is the evidence produced by your employer that shows that these treatments work?

One other thing, you are entitled to your own beliefs, but you are not entitled to your own facts, and the facts do not support your story.

@Dana some of us have spoken to, cared for, treated or lived with former patients of non compliant cell companies and the stories are not all positive. This is sad because much of the problems arise from unclean labs and cells not grown in proper conditions. The success you mention may be there but where is the evidence. Who will look after this to honor medicine and science and the rule of law?

Some patients at cell vendors were even asked to sign statements saying they could face litigation if they shared negative information. it really reminds me of the organ selling trade where a teen in China sold his kidney for an IPAD or in developing nations where clinical research trials kill and mame the unprotected http://www.ithinkwell.org/clinical-trials-accountability-to-reduce-trag…

If there was concern for patients there would also be respect for regulations of Public Health and the FDA and high quality trials would be done without delay. No one is gossiping or stopping science, people have died, GOOGLE it!

incredibly this is about the science not being done for safety and efficacy while calling this medicine and the follow on consequences of this choice. There is good stem cell research in clinical trials why not focus on that?

“Unlike many people, I am not for sale. Because you don’t know me I will forgive your ignorance. I have been writing for a very long time, have sniffed out my fair share of scandals, and have made enemies along the way. I wouldn’t lie for one of my children, much less someone I have been hired by.”

So? I’ve seen plenty of journalists fool themselves into supporting a cause, earnestly believing they are ‘right’, when the evidence is in fact against them. They’re pain because they can mislead others.

Being a “professional writer” doesn’t qualify you to (your words) “look into the current well-being of prior patients”. You have experience in writing. There are a handful of investigative journalists that dig deep well despite a lack of formal background in their subject matter, but your conflation of testimony and evidence shows you’re not in that camp.

“Seriously, what is so difficult about speaking with former trial participants yourself?”

People here look to medical evidence, not anecdote. They tend to look to the research literature. Testimonies are anecdotal and of very limited value in determining if a medical procedure has merit.

“Ask those people who claim that their lives have been saved. It may change your perspective.”

Testimony ≠ solid evidence. See above.

“Choose to believe whatever you want, but don’t be surprised if the day comes when you need adult stem cells and they’re not available to you due to this kind of short-sighted gossip mongering.”

In addition to failure to publish, reliance on testimonials. claiming to cure everything from asthma to zits with the same treatment, charging for participation in clinical trials, the Galleo gambit etc, we can add using low rent PR to the telltale signs of the quack.

This is the reason I decide to post a response, therefore I did not just decide to pop by for no reason.

Orac’s post on 5/6/13.

Of course, EmCell is far from alone; it’s just one of the older and slicker “stem cell” clinics. There are many others, such as the Stem Cell Institute in Panama, the Bio-Cellular Research Organization in Ireland, the Regenerative Medicine Institute in Tijuana, among many others. Astute readers might have noticed that I use scare quotes when I discuss stem cells in the context of these clinics. That’s because it’s very much in doubt in most of these clinics whether what is being administered actually consists of stem cells. That’s where the need for regulation comes in most acutely. It’s also why what is going on in Italy right now is of great concern.

Regarding post # 93

herr doktor bimler

May 9, 2013

Dr. Lopez has spammed the same message to every website he can find that’s vaguely hostile to stem-cell grifting.

My response:

I do not know what this blogger is talking about, I did not spam anything, this was the only post I made.

Regarding post # 100

Grant

May 9, 2013

People here look to medical evidence, not anecdote. They tend to look to the research literature. Testimonies are anecdotal and of very limited value in determining if a medical procedure has merit.

My response:
I could not agree with you more, our IRB approved protocols require to document medical evidence not pt. testimonial information, just recently we underwent an audit by our regulatory agency and were commended for our level of compliance.

To ALL, I say that we have published partial data, as soon as we have completed our CHF and COPD trails all data will be peer reviewed and hopefully we will find a major journal that will publish it.
I have a sense that anything that I write in this blog will be taken seriously, therefore our OFFER STANDS for any qualified SC scientist or researcher that is willing to come down to our facilities to validate our program, to verify that there are IRB approved protocols in place, that all pts. have signed informed consent forms, that no promises have been made regarding cures of any sort, that according to Mexican Health Code researchers are allowed to collect customary and usual fees for medical research as long as this is not viewed as a commercial enterprise, that an important percentage of the monies collected by RMI go back to research and that we work closely with the local University to support research and training for the future health researchers of our state.

I could not agree with you more, our IRB approved protocols require to document medical evidence not pt. testimonial information, just recently we underwent an audit by our regulatory agency and were commended for our level of compliance.

Dr. Lopez, was Ms. Hall, who was charged $25,000 and casually libeled here by your employee, part of a clinical trial?

Having taken a look around Sipp's blog, I couldn't help but notice the similarities between the Celltex story and Burzynski's own efforts to establish an international franchise. It of course has been speculated that Burzynski could easily move across the border, which is exactly what Celltex did.

My comment was to the journalist you hired. I was pointing out that what she offered was testimony, not formal evidence. (Others pointed out as much, too.)

You wrote in response (to me): “I could not agree with you more,”

From this I take it you agree that a journalist’s testimonial examples “are anecdotal and of very limited value in determining if a medical procedure has merit.”

(Also, I note also she hasn’t replied -- have you asked her not to reply?)

In your reply to ‘All’, you seem to saying that you have not yet published material that would enable researchers to judge your treatments. Why hire a journalist to tout ‘successes’ before the results are fully collected or known to researchers?

"So far we've had great results. We're publishing our first work in a couple of weeks," Lopez said, adding that his was the first clinic that agreed to go under the International Cell Medicine Society's accreditation process.

No publications from "regenerative medicine institute mexico" in PubMed.

None for "Angeles Regenerative Institute mexico" or "Ageless Regenerative Institute mexico" either. (The trials Lopez pointed at are run under the latter name; the middle one is from that the RMI is under the "Hospital Angeles of Tijuana".)

None that I can see from Google Scholar either (more confusing output for the later, though, as it picks up things that aren't really papers).

“However, the Angeles Regenerative Institute not only conducts clinical trials, but also commercialises these experimental autologous SC transplants as standard therapy. The hospital markets experimental SC-based therapies, meaning that research subjects undergoing experimental medical practices are being charged for their involvement, as if they were consuming proven medical treatments. This application of experimental SC therapies for financial gain carried out by this institute is in contravention of Article 327 of the GHA, which bans the commercialisation of tissues and cells, as well as of Articles 21 and 22 of the Tissue Regulation and the related
provisions, which forbid the charging of patients who enter clinical trials or who receive therapy derived from tissues and cells.”

Patient-funded clinical trials are ethically very dicey.
The name "patient-funded" can also be very misleading as it is only rarely that patients organize to fund a clinical trial, while the term is most often used to refer instead to for-profit clinics charging any patients who come along to participate and no one who fails to pay can be part of it. But the false implication is that multiple patients consciously and coherently as a group are choosing to fund a trial.

At RMI we have industry sponsored trails and patient funded trails, the later is the case of Bioheart's CHF Angel trail and the University of Baja California School of Medicine Diabetes type II trail, in the case of the pt. funded trails patients from many parts of the globe come to us willingly after being fully informed and in agreement that at least partial cost of the trail is payed by them, i.e. MRI's, CT scan, labs, echo, CA screening, etc., these studies are required to insure that pts. meet inclusion/exclusion criteria, as well as 90 day, 6 month and 1 yr. follow up testing, in addition participants are monitored once a month by phone, in some cases quality of life measurements are also monitored. So far we have treated over 100 pts. mostly CHF and COPD in our experience patients are comfortable with this option. More than 80% of potential inquiries are sadly turned down because of the lack of compliance with trail criteria.
Bloggers are encouraged to read our disclaimer and informed consent form that are posted on our website.

The report you cite refers to the Angeles Regenerative Institute, I am not part of that organization therefore I cannot address it.

What I can tell you is that RMI is not commercializing SC-based therapies as medicines, standard treatments or advanced therapies and we very definitely do not "commercialize" these experimental autologus SC transplants as standard therapy.

The Google English translation of your statement: Article 327 of Ley General de Salud...

"Article 327. ...

"Not be considered commercial acts recovering the costs of obtaining or extraction, analysis, storage, preparation, distribution, transportation and supply of organs, tissues, including blood and its components, and progenitor or stem cells."

Hmmm, what are the costs "to obtain and extract your patients' own stem cells", to "analyze, store, prepare, distribute, transport" and immediately inject them into your patients? Do your also do organ and tissue procurement and is your Institute a blood/ blood apheresis donation site?

The report you cite refers to the Angeles Regenerative Institute, I am not part of that organization therefore I cannot address it.

It quite plainly states that "Among these private medical facilities is the Regenerative Medicine Institute of Hospital
Angeles of Tijuana (referred to as the Angeles
Regenerative Institute) (Grupo Angeles, 2010)." That's you.

Grant and lilady, I linked to that paper earlier in the thread. It came out of a dissertation at the University of Manchester that discusses this whole area.

When I first mentioned it, Dr. Lopez arrived and claimed the laws had been changed, so the concerns raised were no longer applicable. I have not been able to find any evidence so far that the laws were indeed changed in January 2013. Now he is claiming it is not the same institute being referred to, when it very clearly is.

Then there was the claim in the interview from 2011 that the research was to be published "in a couple of weeks", but so far there is no publication.

It is my conclusion from this that Dr. Lopez' statements about his institute and their work are not reliable.

I have not been able to find any evidence so far that the laws were indeed changed in January 2013.

I presume it has something to do with this, but then the question is what reason there is to bring it up other than to assert that now they're not in violation of the law. This might go some way to explaining his peculiar response about not being "part of that organization," so "therefore I cannot address it," if there is some arm's-length arrangement among RMI, Hospital Angeles, and the Ageless Regenerative Institute (which is plainly commercial and part of this outfit; great footnote, BTW).

(As for Bioheart and its "leading position within the cardiovascular sector of the cell technology industry," I'd hate to see the rest of the sector, given that BHRT has never cracked a nickel a share.)

Then there was the claim in the interview from 2011 that the research was to be published “in a couple of weeks”, but so far there is no publication.

See here. Perhaps I'll take a look at the BHRT Form 10-K's later. The thing is that Ageless probably doesn't need to be so transparent, and money is flowing from BHRT to Ageless in the form of the licensing deal, and Ageless is the sponsor for NCT01559051.

I saw that, but I couldn't see how that law change suddnely resolved the issues brought up in the paper. Perhaps because I haven't seen the text. Although I do think it significant that Dr Lopez hasn't backed up his claims by pointing to the specific changes.

Ageless nonetheless has rather close ties to RMI. But I'm not finding any "Angeles Regenerative Institute" at that link; indeed, the only use appears to be in the thesis and corresponding UNESCO document.

I think the best thing to do is wait until Dr. Knoepfler, Orac or Doug Sipp, come down to Mexico and review all documents pertaining to our claims about compliance.

If they cannot travel to Mexico I have also written to Dr. Knoepfler to ask that we meet in Sacramento in the very near future to talk about our program.

For now I do not have the time like most of you apparently have to sit in front of the computer to answer questions that no matter what the response is they will not satisfy you.

Final thought, I think that after this barrage of posts we can all agree that RMI does use adipose derived stem cells in it's trails, that RMI complies with existing Mexican Health Code, that it has posted some partial trail results and that bloggers at this site believe that some of RMI trails do not meet their ethics scrutiny. And yes, we were in compliance before and after the January 2013 changes in the Mexican Health Code, the changes only made things clearer as in Mexico like the rest of the world SC research is a dynamic field and regulatory authorities are trying to keep up.
Such might be the case in the US where there are dozens of practitioners offering cures for neuro degenerative diseases using SC therapies.

Hmph. As of March 26, 2013, on their FY2012 10-K, Bioheart told the SEC the following: "The ANGEL Trial is a Phase I trial and is expected to be conducted at the University of Miami. We are seeking to secure sufficient funds to initiate enrollment in such trial. If we successfully secure such funds, we intend to engage a CRO and certain suppliers to advance the trial." Nonetheless, they put out a press release in October 2012 announcing that it was going to be RMI, after having announced in February 2012 that it was going to be Miami.

In any event, they report that "the LipiCell product is currently being utilized by the Regenerative Medicine Institute of Tijuana, Mexico" (emphasis added). These guys are in atrocious financial shape; it's no surprise that they're charging people for the privilege of providing them with proprietary data.

Oh, and they just lost three-fifths of a defamation case on jurisdictional grounds.

In short: Definitely not the Burzynski model, although the employee directors still seem to be able to pay themselves six-figure salaries.

“[…] like most of you apparently have to sit in front of the computer to answer questions that no matter what the response is they will not satisfy you.”

I can’t speak for others, but for myself: not so, I’m extremely busy and I have not written in the manner you suggest.

“that it has posted some partial trail results”

A small quibble: in #105 you wrote “we have published partial data,” -- I, for one, usually take ‘published’ to mean the research literature. Should we read from this that these results have not been published in the peer-reviewed research literature? This reads as if you have put some partials results on your website.

“I think the best thing to do is wait until Dr. Knoepfler, Orac or Doug Sipp, come down to Mexico and review all documents pertaining to our claims about compliance.”

Wouldn’t the better thing be for your institute to be presenting research results, etc. that can be critically assessed by people familiar with research in this area? (Just my thoughts, etc.)

ChrisP - Sorry I missed your earlier reference to the report. Ageless R. is named in the trials sponsored by RMI that Lopez pointed to in his first comment here.

#134 "I think the best thing to do is wait until Dr. Knoepfler, Orac or Doug Sipp, come down to Mexico and review all documents pertaining to our claims about compliance."

Actually, there's no need for anyone to go anywhere. You can scan those documents and hit "send." Or, if you have no scanner, a cellphone with a camera will probably work too, if it's not a crummy one.

Of course, that still won't be a peer-reviewed publication in a proper journal, but it could potentially be a start.

TIJUANA, Mexico, April 23, 2012 (GLOBE NEWSWIRE) -- Regenerative Medicine Institute, Mexico (RMI) will be among top scientists and physicians presenting cutting edge data at the International Society of Stem Cell Research (ISSCR). The ISSCR's annual meeting has become the world's premier stem cell research event. The meeting serves as the largest forum for stem cell and regenerative medicine professionals from around the world. The ISSCR 10th Annual Meeting will be held June 13 - 16, 2012 at the Pacifico Yokohama in Yokohama, Japan.

A summary of data on the use of adult stem cells from adipose tissue to treat heart failure and COPD will be presented by Kristin Comella, Chief Scientific Officer of Bioheart Inc. Bioheart is focused on the discovery, development, and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. RMI is currently running Phase I/II trials at the Hospital Angeles in collaboration with Bioheart and the Ageless Regenerative Institute.

Dr. Javier Lopez, President and CEO of RMI and a member of ISSCR said that "We are proud to share our initial results with the scientific community at such a prestigious event."

ABSTRACT
The Regenerative Medicine Institute (RMI) of Tijuana, Mexico has partnered with both the Ageless Regenerative Institute (ARI) and Bioheart to offer a variety of clinical protocols to patients suffering from degenerative diseases.
In one protocol, developed and executed by RMI and ARI, patients diagnosed with chronic obstructive pulmonary disease (COPD) are being treated with adipose or fat derived stem cells (ADSCs). To date, 22 patients with COPD have received an intravenous delivery of the stem cells.

The trial has established a solid safety profile as well as some early evidence of efficacy. More than 83% of the patients have demonstrated a statistically significant improvement in their quality of life. Some of this data includes follow up greater than 6 months. The average improvement in the St. George’s Respiratory Questionnaire was 23 points. This represents a potential new breakthrough for COPD patients who often suffer from a rapid decline in health after diagnosis. Existing therapies are designed to target acute symptoms and do not reverse the effects of the disease or improve the underlying issues.

In addition to improving the patient’s quality of life, the treatments showed a marked improvement in their exercise capacity. Three months after receiving the therapy, the patients were able to walk on average an additional seventy meters in their six minute walk test.

RMI and ARI have also partnered with Bioheart to bring regenerative therapies to cardiac patients. In a protocol focused on congestive heart failure (CHF), 15 patients have been successfully treated using adipose derived stem cells. The cells are delivered directly into the heart muscle using a catheter. These patients have demonstrated on average, an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their 6 minute walk distance at their 6 month follow up. In addition, the patients have improved their exercise capacity which allows for a more active and normal lifestyle.

In a third protocol with RMI, ARI and Bioheart, the cells are utilized in non-healing ulcer wounds. A case study for radiation necrosis demonstrates complete healing after 6 months.

So where's the publication in a peer-reviewed scientific journal, Dr. Lopez? That conference was almost a year ago. That's usually long enough to go from an abstract presented at a conference to a peer-reviewed scientific publication in the biomedical literature.

Oh, and two more questions: Was the study randomized? Was it double-blinded? If it wasn't, it's just a one-arm observational study, and your observations can very likely be explained all or in large part by placebo effects and biases. Pilot studies are well and good for hypothesis generation and providing groundwork to do larger, more rigorous clinical trials, but they're not enough to justify routine use of a treatment, particularly as one as complex and fraught with potential problems as stem cell therapy. They are at best, even if completely as advertised, preliminary.

I think the best thing to do is wait until Dr. Knoepfler, Orac or Doug Sipp, come down to Mexico and review all documents pertaining to our claims about compliance.”

Apparently Dr. Lopez hasn't heard of little things called a scanner and e-mail. Or he could scan the documents and post the PDFs on his website. There is no need for me to travel to Tijuana just to see documents or tour a site. If he were so inclined, Dr. Lopez could make whatever information is necessary to convince skeptics available by e-mail or on the web.

By the way, would anybody like to compare this RMI blog entry with this one-off Blogspot effort? I seem to be picking up on some similar themes.

We encounter the indefagitable Dana George declaring jihad against Doug Sipp on a sct-spamsite here, all in the cause of personal integrity.

The first thing I said when asked to do some writing for Regenerative Medicine Institute, Mexico was, "I'll give it a stab, but if I find out there's anything unethical going on, I'm done." Honestly, this is not only my reputation, but my family name on the line. I just don't get how someone could put a price on his family name.

By the way, would anybody like to compare this RMI blog entry with this one-off Blogspot effort?
Note that it refers back to an earlier Blogspot site set up specifically to attack Doug Sipp:
sctmonitored.blogspot.com
In this case the anonymous blogger maintained the enthusiasm to keep posting from August to October 2012. The blogger complains about the unethicality of Sipp's "posts on the Regenerative Medicine Institute in Tijuana", sadly without linking to them.

For anyone curious about the pro-stemcell legislative change in Mexico, Dana George has contributed a report to a magazine here, in which she singles out RMI for particular praise:www.medicaltourismmag.com/download/issue-25.pdf
(already noted by MSII back at comment #87).

herr doktor bimler, would you please explain how you came to the conclusion that RMI has a business partner and supplier?

Are you suggesting that Stemedica has a financial or other kind of interest in RMI?

If this is the case please let me assure you that this is not the case, RMI is owned by a Mexican Corporation and has no business partners, not Hospital Angeles Group nor any other entity that might be implied.

herr doktor bimler, would you please explain how you came to the conclusion that RMI has a business partner and supplier?

Well, I'm not HDB, but don't you receive royalties from Bioheart on a per-patient basis and employ the exclusive LipiCell™ technology, licensed by tiral sponsor Ageless to Bioheart, which requires someone to supply the exclusive LipiCell™ techology?

Well, this is all very strange. Dr. Lopez denies any relationship with Hospital Angeles Group.

However, this website http://www.stemcellmx.com/stem-cell-therapy-programs/ brought to you by Angeles Health only mentions RMI in the disclaimer. If RMI and Angeles Health were separate entities with no relationship, why isn't Angeles Health mentioned in the disclaimer?

It would appear that the relationship between RMI, Hospital Angeles Group, Medical Tourism Mexico is a lot cosier than Dr Lopez wants to let on.

We encounter the indefagitable Dana George declaring jihad against Doug Sipp on a sct-spamsite here

Indeed. I presume that the Barbara who is pleading Dana's case at Knoepfler's blog is the same Barbara Hanson. Ms. Hall is dealt with in an interview with co-Pioneer (and partner in SeaChange Therapeutics)* Jeannine Richardson here.

* Who would have thought that a remedy for food poisoning also takes care of warts?

We DO NOT conceal anything everything that we do is out there for scrutiny.

# 154

The only relationship that we have with Hospital Angeles Tijuana is one where they provide their hospital services (hospitalization, labs, imaging, surgical suites, etc.) in order for us to run our trails. Angeles Health International is a sub-division of Angeles Health Corp. that promotes services offered at their 22 hospitals.

As per Orac's kind suggestion we are going to post the preliminary data that was reported in the way of a poster at the ISSCR meeting in Yokohama in 2012.

Back in 2010, we presented preliminary data at the Asociacion Nacional de Cardiologos de Mexico", at that time the paper was selected by peers to be published in the Mexican Journal of Cardiology and was given the highly prestigious "Maestro Carlos Perez Treviño" award.

In 2011 after more data had been collected a paper was presented at the International Cardiology Congress in Guadalajara, Jalisco at that time it was warded the BEST RESEARCH paper of the year.

Bioheart has also presented preliminary data at no less than half a dozen Cardiology meetings in the US and Canada.

Our goal is to write and submit for peer review papers for our COPD and CHF trails, if you all are patient and give us the benefit of the doubt these papers will be out for your review this summer.

Back in 2010, we presented preliminary data at the Asociacion Nacional de Cardiologos de Mexico”, at that time the paper was selected by peers to be published in the Mexican Journal of Cardiology and was given the highly prestigious “Maestro Carlos Perez Treviño” award.

I presume that paper would be this (PDF). The thing is that there seems to be more to RMI than just the Bioheart-related work.

Dear Narad, in fact that is the document in reference, as posted at clinicaltrails.gov website under trail identifier NCT01502514 Dr. Juan Parcero is the Principal Investigator for that particular trail, you will also note that he credits Dr. Warren Sherman from Columbia University Medical Center (Dr. Sherman trained Dr. Parcero to perform de intra myocardial SC implant) along with RMI physicians. By tomorrow you will find posted on our website all documents pertaining to this matter.

Who would write these vicious cowardly little spoof blogs against Doug Sipp? They obviously know they are being libelous.Does anyone care to name the author(s)?

It is my opinion that someone like these bullies should never be entrusted with vulnerable patients.. Seeing this propaganda endorsed by those why purport to practice medicine is evidence that they are incapable of self managing any medical regulation because they can't even control themselves and somehow delude themselves into thinking this behavior is acceptable and worthy of respect.

I had the experience of being falsely accused of collaboration with Doug Sipp because I appeared in one of the posts so I read them. I found Doug Sipp linked to publicly available verifiable information.

He didn't need to be a doctor just a concerned citizen who knows how to read and write and who cared enough to do something about the problem he saw. Doug Sipp created a timeline and a history that anyone can trace and from there make up their own minds. It would take a lot of work to compile all this information.

I also find that those who disparage him and his background do not have their publications in the same tier of journals that he does. Science and Nature are major profile with high standards so all the more power to him if he got there with a lesser volume of education than those who slander and disparage.

It was not the writing or the opinions that moved me as much as it was the meticulous collection of downloads and legal papers and the sheer ruthlessness of some of the personalities.

Alain, that blog appears to have been set up to defend the ICMS and Stemedica and to attack Doug Sipp. It was only active for a period of 7 weeks and all the articles are signed 'Doug Sip' except one where the author has made a mistake and added an extra p. I find it extremely dubious.

Doug Sipp is a communicator employed by RIKEN. RIKEN is a major Japanese research institute with a very good scientific reputation. Doug Sipp is not a scientist, but a communicator. It appears that the attacks on Doug Sipp are motivated by his criticisms of various players in the stem cell therapeutic business.

I am not an expert in stem cells, but I did find Sipp's analysis to be measured and back by citations. In contrast, that blog is a good example of the sort of activity of those who criticise Sipp. I am certainly leaning towards Doug Sipp's point of view compared to his opponents.

Chris P, It doesn’t matter who I am or what kind of judgment you make about me, it is your choice. Thank you for at least giving this some thought. I would like to see the dissertation you referenced, work like this is so needed.

I was unfortunate collateral damage that was caught in the crossfire through my own ignorance and vulnerability. Nothing excuses this but I offer the following explanation as others could get caught in the same trap.

I care for patients and vulnerable persons and I want the best for them, I also care about research, science and medicine.

I hope you will somehow be able to look past the history and see the need for clinical trials that are registered, report all data, are ethical and that you find that even though the FDA is not perfect at least there is a standard and people are not hurt from profit mavericks masquerading as science because rules to protect vulnerable participants and standards for clinics are in place.

I worked for the people mentioned by Doug while recovering from a brain injury. It is something I am not proud of and I regret. Like Dana I was science and ethics naïve and wrote “educational” materials for the Spinal Injury foundation AKA as ICMS.

I take full responsibility for my ignorance and I will live for the rest of my life knowing individuals may have decided to have cell experimentation outside of an FDA compliant clinic because of something I wrote in the past.

At the time I knew nothing of bias, blinding, allocation concealment, placebo effects or even inadequate biased reviews or safety papers. I believed what I was told. I thought doctors self managed and were by nature ethical and put patients first. I hope for most doctors this is true.

Doug Sipp found through his searching on the now defunct website Spinal Injury Foundation that I was a former Executive director. What he found out about these individuals and companies was way beyond anything I knew or could have given him. I wish I had known earlier. Being linked was not something that I am proud of. Still I commend Doug for publishing history even though it is something I would prefer to put behind me.

I am not a stem cell scientist, journalist, or MD. I am just an ordinary person who made a mistake and have taken steps so as not to repeat the process or do more harm than good.

I am thankful for evidence based healthcare training at Oxford University that enables me to make better future choices.

As to the comments on my PhD on the troll blog, perhaps it would help you to understand they were professional rather than academic. This is acceptable to UK parliament and internationally. I have never made any secret of this or paraded as an MD etc. In reality the spam and vitriolic slander you link too only hurts vulnerable people such as many I work with.

Pursuing academic credentials that required advanced science and ethics helped me to learn that what those that made the documents available to the trolls for posting was doing was not acceptable. Further training in evidence based health care confirmed this.

I am deeply ashamed to have ever had anything to do with them and I know first and second hand how it is to be vulnerable and willing to pay anything to be free from pain. I have family members, friends and acquaintances that have had unsuccessful stem cell ‘treatments’

Alain,
No worries Alain it is hard to fathom, I don't actually know. why they would do this to anyone. They remain anonymous except there is only one source the legal documents could originate from. I was an easy target and that is what bullies look for. They can only discredit me by implying I am a lying lunatic with an axe to grind just like they did with that poor patient with incurable liver disease who they relieved of tens of thousands of dollars.

Let's put me aside as it is a distraction, the important thing is the safety of patients and their rights to ethical, effective and regulated treatment and the potential harms that come to populations when laws of the land are scorned by some with a medical license and the contributions of dedicated and ethical scientists are marginalized.

Vulnerable patients should never be used as human shields against regulators by medical practitioners it is a violation of trust.

The paper from Italy and the decisions that were made are sad. I am thankful that ORAC has given this attention, perhaps we can stand up for our scientists and respect them so what happened in Italy doesn't happen here.

Just to clarify, I am not implying that the patient that was vilified and called troubled for wanting her money back after failed cell therapy and the group that disparaged me are the same individuals. I was using the example to show the common strategy. Both groups do have association with ICMS.

Interesting paragraph on supervision of Stamina in Italy at Stem Cell Assays http://stemcellassays.com/2013/05/cells-weekly-19-2013/ Interesting that Dr Lopez did at least register his trials. What kind of blinding/placebo/standardized care is required for cancer end of life trials. Would it be fair to compare to this?

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Well, QEDCon is over, and this box of blinky lights is on its way back across the pond to its home in the US, having had an excellent time imbibing skepticism from its (mostly) British and European partners in skepticism.
Before I left, I made a somewhat cryptic remark about "major changes" to this…

As you probably noticed, I didn't manage a post yesterday. Nor did I manage one today, other than this. That's because I was busy preparing for QEDCon, where I will be on a panel and giving a talk, and, of course, putting together my talk. As I write this, I'm horrendously jet lagged; so I probably…

QEDCon is fast approaching (indeed, I can't believe I have to leave for Manchester tomorrow night), and because my talk there will be about the phenomenon of "integrative medicine," I've been thinking a lot about it. As I put together my slides, I can't help but see my talk evolving to encompass…

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As I write this, I'm told that there are eleven water cannon vehicles heading to the disaster-stricken Fukushima Daiichi nuclear power plant, to attempt to cool down nuclear material that is exposed and exuding (I dare not use the word "leaking" lest I be thought an alarmist) radiation at a rate that seems to be as alarming to the engineers and nuclear experts on the scene as it is assuaging to…

Prepare yourself.
The Te Papa Museum of New Zealand has a new specimen locked in a vault: a colossal squid that will be thawed and dissected (they think!) on streaming video.
Here is the necromantic chamber.
Wait! No protective runes, no array of emergency thuribles, no pentagram, no mysterious idols of jade and obsidian? This may not go well.